510(k) DEN230025
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 23, 2024
- Date Received
- April 11, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table Mounted Miniaturized Electromechanical Surgical System
- Device Class
- Class II
- Regulation Number
- 878.4962
- Review Panel
- SU
- Submission Type
A table mounted miniaturized electromechanical surgical system is a software-controlled electromechanical system with surgical table mounted patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures where the software-controlled electromechanical devices miniaturized and compact size allows the effective element of the system to be inserted into the body cavity and use surgical instruments attached to the electromechanical arms